The BioPharm industry presents a wide variety of opportunities for medical writers and editors. There are jobs for people with undergraduate, graduate and doctoral training; many medical writers are MDs, PharmDs, or PhDs. Most medical writers have scientific training but some, especially medical editors, may have training in English or Journalism.
Some medical writers are employees of pharmaceutical or biotech companies. Some writers work for CROs, either CROs that specialize in medical writing or in the Medical Writing departments of CROs that provide multiple services. Some medical writers are independent, freelance contractors.
As we have discussed, the BioPharm industry is heavily regulated. Almost everything done must be documented and summarized for regulatory submission. Much of this writing is done by the bench scientist or clinical monitor who has done the work, but the help and guidance of an experienced medical writer is critical to completing big projects in a timely fashion.
Medical Writers in industry write for many audiences including physicians, pharmacists, regulatory reviewers, patients, the public, stockholders, etc. Medical writers draft document such as protocols, Investigator Brochures, Clinical Study Reports (CSRs), and regulatory submissions such as INDs, and NDAs. Medical writers in industry also prepare educational materials about marketed products, such as slide sets and product monographs as well as scientific information for press releases.
Some medical writers specialize in regulatory documentation; others edit articles for journal submissions; whereas others focus on educational materials. But most are generalists and take on a variety of jobs.
Medical writers must be talented communicators; they must be able to interpret scientific and medical information clearly and summarize the results grammatically. They must be skilled in word processing to format tables, figures, and diagrams. They must be able to work independently but also collaborate with multidisciplinary teams on large complicated documents. For these projects they must be able to track multiple drafts and coordinate the work of multiple contributors. The hardest part of being a writer may be taking criticism, i.e. literary criticism. When working on a large document like an NDA, some companies call together groups of physicians, CRAs, regulatory directors, scientists, and executives to draft the documents. Every word, comma, and hyphen is scrutinized and there are many egos that must be soothed and balanced. After a day or two of discussions, it is often left to the writer to collect everyone’s contribution and blend them together without losing the integrity of the document.
I have worked with many very talented medical writers. One of the best I know had a PhD in Psychology and entered the pharmaceutical industry after working in a law firm. She has a way of seeing study results clearly and summarizing the data succinctly. I have always said that you could give her everything in the shred bin and she could draft two final reports and a publication. It is a lesson in humility to have her edit your documents but the final results are worth it.
The American Medical Writers Association (AMWA) is a national organization for writers in industry and academia. The AMWA provides some excellent online courses and regional and national workshops that can lead to Certification in Essential Skills; Composition and Publication; or Regulatory and Research. Their regional chapters sponsor local meetings that are good places for networking. This is a link to the AMWA website.
Another place to find practical information about medical writing for industry is a blog site called www.BioInkSpots.com written by Dr. Susan E. Caldwell.